# FDA recall Z-2249-2018

> **Vascular Solutions, Inc.** · Class II · device recall initiated 2018-05-04.

## Product

Drainer(R) Centesis Catheters:  (a) REF 8810, 5F x 9cm  (b) REF 8811, 6F x 9cm  (c) REF 8812, 5F x 15cm    Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.

## Reason for recall

The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2249-2018
- **Recalling firm:** Vascular Solutions, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-04
- **Report date:** 2018-06-27
- **Termination date:** 2020-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2249-2018

## Citation

> AI Analytics. FDA recall Z-2249-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2249-2018. Source: US FDA. Licensed CC0.

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